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Associate Director of Assay Development

Carolina Pharmaceutical Research

This is a Full-time position in Kelly, NC posted November 15, 2021.

**Kelly Services is currently seeking an Associate Director of Assay Development** **for a Direct Hire role in San Diego.**

**Job Title** : **Associate** **Director of Assay Development**

This new role is responsible for assay transfer from research and development to QC, enhancing current assays and methodologies and supporting assay qualification.

As a growing organization, we are looking for deep scientific background in cell or molecular biology and a passion for driving toward key milestones as we develop a novel autologous neuron replacement for both sporadic and genetic forms of Parkinsons disease.

You will lead innovation, design and execute experiments to develop new assays and ensure successful qualification/validation, implementation and regulatory approval.

**Responsibilities** :

Responsible for Assay Transfer from Research, optimization of assays, assay qualification

Manages outside testing which moves over to QC

Develop and execute qualification/validation of assays using cellular immunological techniques including proficiency in single-nucleotide polymorphisms (SNP) panel array and Whole-genome sequencing (WGS), Copy number variations (CNV) array, cell count and viability, flow cytometry, and qPCR

Qualify laboratory instrumentations

Perform in-depth data analysis and interpretation and document all work in the form of laboratory notebook, study reports, and presentations

Author technical and regulatory documents as requested

Hire, train and develop assay development technicians and scientists with the growth of the organization.

**Education and Experience** :

Masters required, PhD in cell or molecular biology preferred

5-8 years of experience in pharmaceutical, biotechnology, or academic research setting with cell therapy, cell-based assays or experience relevant to development of cell therapy (if not exact)

Background in quantitative PCR (qPCR), and flow cytometry assays

Experience in assay qualification and formal assay qualification preferred

Experience in assay validation

Solid understanding of statistical tools such as JMP, and / or Python

**Job Specifications** :

Proven skillsets in managing assay transfer, qualification, and validation

Demonstrated leadership skills with a passion for building a productive, collaborative, team environment.

Expertise in cell culture, genomic analysis, qPCR, flow cytometry is required

Ability to organize, communicate, and present complex data sets to the team

Ability to perform aseptic cell culture of cell lines

Total Rewards and Culture

The company, located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need.

The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you.

Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential.

In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).

Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.

Equal Employment Opportunity is The Law.

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